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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
510(k) Number K180202
Device Name Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
Applicant
Immuno Concepts, N.A. , Ltd.
9825 Goethe Rd., Suite #350
Sacramento,  CA  95827
Applicant Contact Eric S Hoy
Correspondent
Immuno Concepts, N.A. , Ltd.
9825 Goethe Rd., Suite #350
Sacramento,  CA  95827
Correspondent Contact Eric S Hoy
Regulation Number866.5660
Classification Product Code
DBL  
Subsequent Product Code
PIV  
Date Received01/24/2018
Decision Date 10/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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